T2 Biosystems Announces FDA 510(k) Submission to Expand Use of the FDA-Cleared T2Candida Panel to Include Pediatric Testing
04 January 2024 - 1:00AM
T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid
detection of sepsis-causing pathogens and antibiotic resistance
genes, today announced that it has submitted a 510(k) premarket
notification to the U.S. Food and Drug Administration (FDA) to
expand the use of its FDA-cleared T2Candida® Panel to include
pediatric testing.
The T2Candida Panel is the only FDA-cleared
diagnostic test able to detect sepsis-causing Candida pathogens
directly from blood, in just 3-5 hours, without the need to wait
days for a positive blood culture. The T2Candida
Panel runs on the FDA-cleared T2Dx® Instrument and
simultaneously detects five Candida species – including Candida
albicans, Candida tropicalis, Candida
parapsilosis, Candida krusei, and Candida glabrata. According
to the U.S. Centers for Disease Control and Prevention, up to 95%
of all invasive Candida infections in the U.S. are caused
by the five Candida species detected by the T2Candida Panel.
According to the Journal of Fungi, a
peer-reviewed scientific journal that provides an advanced forum
for studies related to pathogenic fungi, Candida species are a
major contributor to morbidity and mortality in hospitalized
children. Additionally, children with invasive candidiasis present
a significant burden to the U.S. healthcare system, with a mean
increased hospital length of stay of 21 days and approximately
$92,000 in excess hospital costs.
"This FDA submission marks another important
milestone in our commitment to expand the clinical utility of our
sepsis test panels and we look forward to working through the
premarket review process to obtain clearance,” stated John Sperzel,
Chairman and CEO of T2 Biosystems. “Candidiasis disproportionally
affects critically ill children, and we believe a pediatric testing
claim for our FDA-cleared T2Candida Panel will allow clinicians to
improve outcomes and reduce cost by achieving faster targeted
antifungal treatment for their pediatric patients.”
A Journal of Clinical Microbiology (2022) study
conducted at the Bambino Gesù hospital in Rome, Italy found that
pediatric patients suspected of fungal bloodstream infections that
were tested with the T2Candida Panel received species
identification results 121.8 hours faster compared to blood
culture. The study also found a higher detection rate with the
T2Candida Panel as six additional probable or possible fungal
bloodstream infections in pediatric patients were detected by the
T2Candida Panel and missed by blood culture. In addition, a
prospective observational study published in Clinical Infectious
Diseases (2022) evaluated the performance of four pre-blood culture
tests for detecting the presence of invasive candidiasis in
pediatric patients and found that the T2Candida Panel had the
highest sensitivity and specificity of all four assays among five
hundred patients enrolled. T2Candida was the only test recommended
for individual use as a tool for the diagnosis of invasive
candidiasis in at-risk children and adolescents.
About T2 BiosystemsT2
Biosystems, a leader in the rapid detection of sepsis-causing
pathogens and antibiotic resistance genes, is dedicated to
improving patient care and reducing the cost of care by helping
clinicians effectively treat patients faster than ever before. T2
Biosystems’ products include the T2Dx® Instrument, the T2Bacteria®
Panel, the T2Candida® Panel, the T2Resistance® Panel, the
T2Biothreat™ Panel, and the T2SARS-CoV-2™ Panel and are powered by
the proprietary T2 Magnetic Resonance (T2MR®) technology. T2
Biosystems has an active pipeline of future products, including the
T2Cauris™ Panel, and T2Lyme™ Panel, as well as next-generation
products for the detection of bacterial and fungal pathogens and
associated antimicrobial resistance markers. For more information,
please visit www.t2biosystems.com.
Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
All statements contained in this press release that do not relate
to matters of historical fact should be considered forward-looking
statements, including, without limitation, statements regarding the
ability of the T2 Candida Panel to detect Candida species in
pediatric patients, the likelihood that the FDA will approve the
expanded use of the T2Candida Panel, and the ability of the
T2Candida Panel to allow clinicians to improve outcomes and reduce
cost by achieving faster targeted antifungal treatment for their
pediatric patients, as well as statements that include the words
“expect,” “may,” “should,” “anticipate,” and similar statements of
a future or forward-looking nature. These forward-looking
statements are based on management’s current expectations. These
statements are neither promises nor guarantees, but involve known
and unknown risks, uncertainties and other important factors that
may cause actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements, including, but not limited to, (i) any inability to (a)
realize anticipated benefits from commitments, contracts or
products; (b) successfully execute strategic priorities; (c) bring
products to market; (d) expand product usage or adoption; (e)
obtain customer testimonials; (f) accurately predict growth
assumptions; (g) realize anticipated revenues; (h) incur expected
levels of operating expenses; or (i) increase the number of
high-risk patients at customer facilities; (ii) failure of early
data to predict eventual outcomes; (iii) failure to make or obtain
anticipated FDA filings or clearances within expected time frames
or at all; or (iv) the factors discussed under Item 1A. “Risk
Factors” in the Company’s Annual Report on Form 10-K for the year
ended December 31, 2022, filed with the U.S. Securities and
Exchange Commission, or SEC, on March 31, 2023, and other filings
the Company makes with the SEC from time to time, including our
Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.
These and other important factors could cause actual results to
differ materially from those indicated by the forward-looking
statements made in this press release. Any such forward-looking
statements represent management’s estimates as of the date of this
press release. While the Company may elect to update such
forward-looking statements at some point in the future, unless
required by law, it disclaims any obligation to do so, even if
subsequent events cause its views to change. Thus, no one should
assume that the Company’s silence over time means that actual
events are bearing out as expressed or implied in such
forward-looking statements. These forward-looking statements should
not be relied upon as representing the Company’s views as of any
date subsequent to the date of this press release.
Investor Contact:Philip Trip Taylor, Gilmartin
Groupir@T2Biosystems.com 415-937-5406
T2 Biosystems (NASDAQ:TTOO)
Historical Stock Chart
From Apr 2024 to May 2024
T2 Biosystems (NASDAQ:TTOO)
Historical Stock Chart
From May 2023 to May 2024